Status
Completed
Phase
Not applicable
Enrollment
38
Locations
1
Results
Not posted
Publications
1
Study summary
To investigate whether administration of calcitonin gene-related peptide (CGRP) binding monoclonal antibodies eptinezumab prevents pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) induced migraine attacks in migraine without aura patients.
The aim of the present study is to investigate whether \- CGRP binding monoclonal antibodies eptinezumab prevents PACAP-38 induced migraine attacks in migraine without aura patients. Clinical and basic research have established calcitonin gene-related peptide (CGRP) as central molecule in migraine pathophysiology, yet existing CGRP antagonizing therapies such as the CGRP and CGRP receptor binding monoclonal antibodies are only effective in 50-60% of migraine patients. PACAP-38 and CGRP colocalize in the trigeminovascular system, and both activate adenylate cyclase upon receptor binding which causes increased formation of cyclic AMP (cAMP). It is unknown if CGRP and PACAP-38 signaling pathways differ sufficiently for PACAP-38 to be an alternative treatment target to CGRP. Whether administration of CGRP binding monoclonal antibodies eptinezumab prevents PACAP-38 induced migraine attacks in migraine without aura patients is yet to be investigated.
Interventions
DRUG
Eptinezumab or ALD403 is a humanized anti-calcitonin gene-related peptide IgG1 monoclonal antibody that binds to calcitonin gene-related peptide (CGRP). It selectively binds human CGRP ligand to prevent activation of the CGRP receptor and blocks its binding to the receptor for the prevention of migraine.
DRUG
PACAP-38 is a naturally occurring peptide diffusely expressed throughout the body. The Danish Headache Center has used infusion of PACAP-38 for several years and the first time in 2007 where infusion of PACAP-38 triggered headaches and migraines in migraine patients.
Timeline
First posted
Dec 2, 2022
Study start
Mar 1, 2023
Primary completion
Aug 4, 2023
Study completion
Aug 4, 2023
Results posted
Not reported
Registry updated
Dec 4, 2023
Outcomes
A subjective report of a migraine attack
Time frame · Time of reporting migraine attack is from the baseline to 24 hours after eptinezumab/placebo administration.
The participants report whether they feel a migraine attack (Yes or no).
Headache
Time frame · Time of headache measurements is from from the baseline to 24 hours eptinezumab/placebo administration.
Headache intensity will be recorded by numerical rating scale (NRS) from 0 to 10 (0, no headache; 1, a feeling of pressure; 10, worst imaginable headache).
Changes in the superficial temporal artery (STA).
Time frame · Time of headache measurements is from from the baseline to 24 hours eptinezumab/placebo administration.
Diameter of the frontal branch of the superficial temporal artery (STA). Repeated measurements covering the diameter of STA before and after eptinezumab/placebo administration and PACAP-38 infusion measured by millimeters (mm).
Eligibility
Inclusion Criteria: * Healthy volunteers of both sexes. * 18-60 years. * 50-100 kg. * Women of childbearing potential must use adequate contraception * History of migraine without aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria. * No migraine preventive treatment. Exclusion Criteria: * A history of serious somatic disease * \> 50 years of age at migraine onset. * History of any other primary headaches disorder (except ≤ 5 monthly days with tension- type headache). * Daily intake of any medication except contraceptives
Study locations
Denmark. Showing up to 24 locations stored in the fast local snapshot.
Danish headache center
Glostrup Municipality, Denmark
Publications
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